Generic Zyrtec tablets recalled over possible heartburn drug contamination
The FDA says four lots of cetirizine hydrochloride 5 mg tablets may contain ranitidine contamination after discoloration was spotted.
By Sal Moretti · Money Reporter
2 min read
A generic allergy pill sold nationwide is being recalled after a pharmacy technician noticed odd markings and discoloration on some tablets, the Food and Drug Administration said.
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., is voluntarily recalling cetirizine hydrochloride tablets USP 5 mg, an antihistamine commonly used for seasonal allergies. The drug is a generic version of Zyrtec.
The FDA said the recall involves possible cross-contamination with ranitidine, a medication used for heartburn. Unique Pharmaceutical Laboratories announced the recall on July 18, according to the agency’s recall notice.
How the problem was spotted
According to the FDA, a pharmacy technician found what was described as a red dot on some cetirizine tablets while counting and bottling the medicine. Other tablets appeared discolored, which raised concern about a possible quality problem.
The agency said people who are hypersensitive to ingredients in ranitidine could suffer adverse reactions if exposed. The FDA listed possible reactions including low blood pressure, shortness of breath, trouble swallowing, loss of consciousness and other life-threatening responses.
No adverse events tied to the recalled allergy tablets have been reported, the FDA said.
The recalled lots
The affected tablets were distributed by Rising Pharma Holdings Inc. to retailers across the United States. The medicine was packaged in bottles containing 100 tablets.
The recall applies to the following lot numbers, all with an expiration date of October 2028:
- GY825029
- GY825030
- GY825031
- GY825032
Rising Pharma Holdings has informed its customers about the recall and is organizing the return of the affected products, according to the FDA.
What consumers can do
Consumers with questions can contact Rising Pharma Holdings by phone at 1-844-874-7464. The company can also be reached by email at [email protected] or [email protected].
The FDA said patients should contact their health care provider if they experience problems that may be related to the potentially contaminated tablets.
This story draws on original reporting from CBS News.